FDA-Drug2022-09-14Class II

CORRECTDOSE Children's PAIN RELIEF & Fever Reducer, Cherry, (Acetaminophen 160 mg per 5 mL), 2.04 FL.OZ (60mL), packaged in 12-5mL individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-311-05 UPC 8 60003 67145 0

Plastikon Healthcare LLC
Hazard

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Sold states
Distributed Nationwide in the USA
Affected count
1,464 ampoules
Manufactured in
3780 Greenway Cir, N/A, Lawrence, KS, United States
Products
CORRECTDOSE Children's PAIN RELIEF & Fever Reducer, Cherry, (Acetaminophen 160 mg per 5 mL), 2.04 FL.OZ (60mL), packaged in 12-5mL individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-311-05 UPC 8 60003 67145 0

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1493-2022

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